Diagnostics Move Home – How to Ensure Your Product Keeps Up with the Next Generation

The in-vitro diagnostic (IVD) device market is growing at an accelerated pace. Grand View Research recently reported that the global IVD market size was valued at $59.40 billion USD in 2017, made up of instruments, reagents, and software.

As with other medical technology sectors, the diagnostic market is seeing a shift toward home care. This same study reports that within that valuation, the home-care segment of the IVD market is expected to register the fastest compound annual growth rate (CAGR) of 8.48% by 2025. This market growth, combined with the shift in point-of-care diagnostics from clinical settings to patients’ homes, presents exciting innovation opportunities for diagnostic products and companies.

In this article, I examine the transition of IVD’s into the home and discuss current trends that will ensure your product keeps up with the next generation of diagnostics and is successful in the competitive home market.

The Next Generation of Home IVD’s - A Holistic Platform

The FDA requires home IVD tests to produce lab-quality results; this created a long-running barrier for transitioning IVD’s into the home. For many years, at-home diagnostic tests were limited, with pregnancy tests and blood glucose tests for diabetics among the most common. Then, technology advanced such that at-home kits became available for testing for HPV, HIV, Strep A, Urinary tract infections, Thyroid (TSH), cholesterol, food sensitivities and more.

However, the newest generation of IVD’s used in the home setting gives patients more than just the same results they would get in the doctor's office. The most intriguing home IVD products on the market offer holistic platforms that deliver more than just results by combining the test, actionable results, digital records, and communication with the physician, patient and appropriate caregivers. This combination offers cost-effective convenience, empowers patients in their health management and may improve their outcome.

One example, Abbott’s FreeStyle Libre continuous glucose monitoring system, eliminates the painful, frequent finger prick testing and instead monitors the patient's blood sugar day and night using a small sensor attached to the upper arm. Patients wave a handheld reader over the sensor to see the current blood sugar level displayed on the reader interface. This device also shows changes over the past eight hours and alerts the patient if their number is above or below a certain threshold.

Standard glucose meters (used by 30 million Americans) require multiple finger pricks each day and only provide a snapshot for one point in time. This product creates a platform that combines cutting-edge sensor technology and consumer electronics technology to remove one of the most significant pain points for diabetics (the finger prick), while also empowering the patient with more information to manage their disease carefully.

Currently, Abbott’s system only monitors a patient’s blood glucose levels. However, future developments will likely build on this platform to include a direct connection to smart insulin pens or pumps to facilitate or automate injections.

Room to Innovate

From cutting-edge medical breakthroughs to broader acceptance by hospital systems and regulatory bodies, in-home IVD’s are embracing the latest technology advances learned from consumer products. When compared to traditional clinical settings, patients can benefit from more convenient access to services, privacy, and lower costs when using home-based diagnostics.

For example, startup company Athelas is aiming to provide at-home hematology monitoring for oncology patients by bringing blood slide analysis to the home. The company uses finger prick blood sampling to test neutrophils, lymphocytes, platelets, WBCs, morphology, and cell activation – at home, within minutes.

The platform’s device is shaped like a smart home speaker (e.g., Google Home). Patients put their blood sample on a test strip and insert that strip into the device, which then sends results to smartphone software. Patients can track their own white blood cell count and neutrophils for peace of mind. Meanwhile, oncologists receive up-to-the-minute alert notifications when necessary, all while building a research database that has the potential to help all cancer patients.

Shifting from the Medical Staff as Users to Patients as Users

While this shift of diagnostics to the home offers additional flexibility and convenience for patients, it presents different product and user requirements for those developing these products. The key is to ensure you are developing the right product for your new user and their environment.

Designing for home care IVD’s requires detailed attention to the user experience — balancing consumer expectations of how digital products should work with FDA’s expectations for diagnostic results (which must be equivalent to the results of clinical lab and point-of-care diagnostic instruments).

Traditional IVD’s designed for use in a clinical setting assume a trained user with a medical background, such as a lab technician or a nurse, is facilitating the test. IVD’s that are used at home by the patient need to be designed with more rigor to reduce the risk of incorrect results caused by improper use.

This shift from the clinical setting to the home requires thinking through additional risks presented by the patient as a user and the home as an environment. Product owners must include appropriate considerations in the product requirements. This will result in more thorough instructions for use, very clear product packaging, and early usability testing with the patient population to reduce the probability of user errors.

For example, change the product use flow to combine steps to make it easier for the patient to follow the directions, or break the instructions down more granularly so they are as error-proof as possible for the user.

The Potential is Enormous

The potential of in-home diagnostics is enormous. This burgeoning of a digitally-driven home is changing the face of treatment across the healthcare continuum. By focusing on identifying needs and gaps in care, providing immediate feedback and support to patients, and utilizing familiar digital home platforms, new home IVD products will be part of the next generation of diagnostics that will benefit from better user acceptance, improved patient outcomes, and ultimately greater market penetration.